Kusum Healthcare General Manager Quality Assurance Interview Questions and Answers

Q1. Tell me about change Control? And give me One Example?
Ans. 
Change control is a process used to manage and document changes to a system or process.
• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more
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Q2. What are the ypes of Process validation?
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Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.
• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more
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Q3. How you are doing Audit trail?
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Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.
• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more
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Q4. Asking about APQR
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Q5. Are you interested in Microbiology analytical review?
Ans. 
Yes, I am interested in Microbiology analytical review.
• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more
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Q1. Purified water specification?
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Purified water specification refers to the set of requirements and standards that purified water must meet.
• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more
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Q2. Purified water specification of Microbal
Ans. 
The purified water specification for microbial quality assurance.
• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more
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Q3. USP chapters of Microbial tesing of API and water
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Q4. Growth Pramotion tests
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Q5. Horizontal Autoclave validation
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Q6. Types of validation
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Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.
• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more
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Q1. Tell me about your self
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Q2. Are you willing to shift Vizag
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Q3. Salary discussion
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Q1. About working responsibilities
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Q2. All technical questions
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Q1. Discuss about your project?
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Q1. Discuss about subject related like disease and drugs
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Q2. Discuss about Quality management system and Data integrity
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Q1. Based on reviews, how to review, preparation documentation
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Q2. How to reviews of pvr& pqrs
Ans. 
Reviews of PVR and PQRS can be conducted through a systematic process involving data analysis and evaluation.
• Collect and analyze data related to PVR and PQRS

• Evaluate the performance and quality based on established criteria

• Identify areas of improvement and develop action plans

• Implement changes and monitor the impact

• Continuously review and update the process to ensure ongoing quality assurance
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Q1. Qualifications related, Family Background, Suitability of working
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Antiviral drugs, Company products

Q1. Pharmacopoeial questions
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Q2. Project related in detail questions
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Q1. Your salary expectation
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Q1. Questions about your profile mentioned in your resume
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Q1. TGA Guidelines Sterilization QMS
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Q2. All mentioned in CV
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